PDS Biotech is making strides in immunotherapy with its Versamune technology, particularly in treating HPV-positive cancers. The company is preparing to initiate a Phase 3 clinical trial evaluating Versamune HPV in combination with pembrolizumab as a potential first-line treatment for recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). This development follows promising results from earlier trials, suggesting a significant improvement in survival rates compared to existing treatments.
Clinical Trial Successes
Data from the MD Anderson-led cervical cancer trial presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024, showed a 100% 36-month survival rate in patients who received chemoradiation (CRT) and all five doses of Versamune HPV. This is compared to the best published 36-month survival rate of 82.6% with CRT and Keytruda.
In a study of first-line recurrent and/or metastatic HPV16-positive HNSCC reported at the European Society for Medical Oncology (ESMO) Congress 2024, the median overall survival was 30 months with Versamune HPV and KEYTRUDA. The best published median overall survival for patients with HNSCC is 17.9 months in the LEAP-010 study.
Versamune Technology
Versamune is designed to harness the immune system to recruit, train, and arm T-cells to attack cancer cells. It induces a higher quantity and quality of highly potent killer T-cells. PDS Biotech is also developing a combination of Versamune with PDS01ADC, an antibody-drug conjugate (ADC) that targets the tumor's inner core, enhancing the T-cell attack against cancers.
Pipeline Expansion
PDS Biotech's pipeline has evolved to include Versamune HPV in advanced HPV-positive solid tumors and PDS01ADC in various cancers, including prostate, liver, gallbladder, and Kaposi sarcoma. The company is also exploring Versamune in MUC1-positive cancers, such as colon, non-small cell lung cancer (NSCLC), and ovarian cancer.
Future Directions
PDS Biotech aims to bring safer, more effective Versamune-based therapies to market in cancers with unmet needs. The company's focus is on targeting the underlying cause of cancer to shrink tumors and extend patient life with well-tolerated treatments. According to Frank Bedu-Addo, CEO of PDS Biotech, head and neck cancer is a silent epidemic, with HPV16 driving an increase in HNSCC cases. The company's immediate goal is to address this growing population by targeting the underlying cause of the cancer to shrink the tumors and extend patient life with a well-tolerated treatment.
